Novel Device for Reducing Catheter-Related Infections

This study has been withdrawn prior to enrollment.
(Never received IRB approval; Withdrawn before enrollment ever started)
Sponsor:
Collaborator:
University of Missouri-Columbia
Information provided by:
University of Kansas
ClinicalTrials.gov Identifier:
NCT00878683
First received: April 7, 2009
Last updated: May 1, 2015
Last verified: May 2015
  Purpose

This study is a pilot study of the safety, tolerability and efficacy of an investigational central venous catheter device used in conjunction with a standard central venous catheter. The hypothesis is that utilization of a catheter device incorporating cyanoacrylate will reduce catheter colonization by bacteria, and may decrease the rate of catheter-related bloodstream infections.


Condition Intervention
Intensive Care
Device: silicone catheter boot

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Exploring the Use of a Novel Device for Reducing Catheter-Related Bloodstream Infections

Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • Catheter site inspection [ Time Frame: Baseline, Daily ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: July 2009
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Device and standard catheter
Device: silicone catheter boot
silicone device using Dermabond
No Intervention: 2
Standard catheter

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Admission in the ICU at time of catheter insertion
  • Indication for central venous catheter placement
  • De novo catheter insertion in the subclavian or internal jugular veins

Exclusion Criteria:

  • Anticipated catheter duration < 72 hours
  • Planned guidewire exchange
  • Documented bacteremia within 48 hours prior to catheter placement
  • Extensive skin breakdown near the site of potential catheter placement
  • Emergent line placement
  • Screening labs with ANC < 500 or platelets < 50K
  • Hypersensitivity to cyanoacrylates or formaldehyde
  • Prior enrollment in study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00878683

Sponsors and Collaborators
University of Kansas
University of Missouri-Columbia
Investigators
Principal Investigator: Stephen Waller, MD University of Kansas
  More Information

No publications provided

Responsible Party: Stephen Waller MD, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT00878683     History of Changes
Other Study ID Numbers: 11525
Study First Received: April 7, 2009
Last Updated: May 1, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Catheter-Related Infections
Infection

ClinicalTrials.gov processed this record on August 30, 2015